To Observe the Impacts of Anti-Tumor Necrosis Factor (TNF) Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis (PsA)

NCT02028169 | Completed Results

• 1 other identifier: P13-518
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This post marketing observational study is designed to provide the initial data on work impairment of PsA patients in Turkey, as well as changes in work impairment, life quality and clinical response during treatment with anti-TNF agents.

Conditions

Psoriatic Arthritis; Work Productivity

Keywords

Work Productivity; Anti-TNFs; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (4)

• Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9

  Absenteeism, presented as the mean percentage of work time missed due to PsA (as reported on the WPAI), and calculated as: 100\*number of hours of work missed due to PsA / (number of hours of work missed due to PsA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

  Baseline, Month 3, Month 6, Month 9

• WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9

  Presenteeism (the extent to which PsA decreased productivity) is presented as the mean percentage of impairment while working due to PsA, and calculated as: 100\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

  Baseline, Month 3, Month 6, Month 9

• WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9

  The mean percentage of OWPI due to PsA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) +\[1- Absenteeism(%)\*Presenteeism(%)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

  Baseline, Month 3, Month 6, Month 9

• WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9

  Activity impairment due to PsA (the extent to which PsA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

  Baseline, Month 3, Month 6, Month 9

Secondary Outcomes (16)

• Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9

  Baseline, Month 3, Month 6, Month 9

• Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9

  Month 9

• Disease Activity Score (DAS 28) Up to Month 9

  Baseline, Month 3, Month 6, Month 9

• Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9

  Baseline, Month 3, Month 6, Month 9

• Dactylitis Score Up to Month 9

  Baseline, Month 3, Month 6, Month 9

Study Arms (1)

Participants Receiving Anti-TNF for PsA

Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from both genders will be included to this non-interventional epidemiological study from selected university or state hospitals or Ministry of Health of Turkey training and research hospitals in Turkey.

You may qualify if:

• Actively working, either full-time or part-time
• Previous confirmed diagnosis of PsA by a rheumatologist
• Patients for whom the physician has initiated PsA treatment with an Anti-TNF in accordance with Turkish Ministry of Health regulations and reimbursement criteria
• Able to provide authorization to use and disclose their health related information

You may not qualify if:

• Patients with a history of an allergic reaction or significant sensitivity to anti-TNF agents
• Patients with possible follow-up problems during the planned study period or patients who may not be compliant to treatment as evaluated by the investigator/treating physician
• Patients participating in any clinical trial of an experimental drug 30 days prior to the baseline visit

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Karadag O, Dalkilic E, Ayan G, Kucuksahin O, Kasifoglu T, Yilmaz N, Koca SS, Yazisiz V, Erten PT, Sayarlioglu M, Terzioglu ME, Erten S, Kalyoncu U. Real-world data on change in work productivity, activity impairment, and quality of life in patients with psoriatic arthritis under anti-TNF therapy: a postmarketing, noninterventional, observational study. Clin Rheumatol. 2022 Jan;41(1):85-94. doi: 10.1007/s10067-021-05893-3. Epub 2021 Sep 3.

  PMID: 34477993 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Mahmut Gücük, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 7, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 27, 2017
• Results First Posted: April 27, 2017

Record last verified: 2017-03